Director / Sr Director - Clinical Development (Pulmonology)

Glenmark Pharmaceuticals; Rimini; In loco; EUR 80.000 - 130.000; Tempo pieno

Descrizione del lavoro

Glenmark Pharmaceuticals is seeking a Head of Clinical Development to lead the progress of drug projects focused on respiratory therapies. This pivotal role requires strong leadership and collaboration with stakeholders, ensuring regulatory compliance while delivering projects from inception through registration. Candidates must have extensive experience in pulmonary medicine and a robust background in the pharmaceutical industry, coupled with excellent decision-making and interpersonal skills.

Competenze

• Minimum 18 years of experience as a practicing pulmonary clinical professional.
• Over 5 years in the pharmaceutical industry.
• Experience in clinical development and regulatory interactions.

Mansioni

• Lead, manage, and mentor Clinical Sciences respiratory projects.
• Contribute to key study-related documents and protocols.
• Support business development for respiratory programs.

Conoscenze

Drug Development

Scientific Advocacy

Interpersonal Skills

Decision-Making

Influencing Skills

Formazione

MD / MS in Internal and Pulmonary / Critical Care Medicine

Descrizione del lavoro

Pls note : Incumbent can be based anywhere in Europe or the US.

Role Overview : This position is intended to head and support the clinical development of new drugs, including conception of innovative approaches to plan clinical studies and support end-to-end drug development in accordance with all applicable regulations and aligning them with the company's business objectives. The role involves discussions with global regulators on respiratory clinical development pathways for facilitating drug approvals, review and due diligence of in-licensing respiratory molecules, and presentations in ad boards and global respiratory meetings.

Job Responsibilities :

1. Lead, manage, and mentor Clinical Sciences respiratory projects to ensure timely delivery of all deliverables.
2. Contribute to and review key study-related documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
3. Review CRO medical monitoring capabilities during study start-up and RFP process, including CVs, MMP, and investigator/site lists for vendor selection.
4. Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO MM, site investigators, and study teams.
5. Review blinded efficacy and safety data, listings, tables, deviations, and support review of blinded SAE or SUSAR documents, addressing or escalating data impacting safety or study integrity.
6. Attend internal or joint CRO-sponsor medical monitoring safety meetings and review medical meeting minutes.
7. Review blinded medical coding for AEs, SAEs, medications, and medical history, and interpret efficacy and safety data after unblinding.
8. Support business development for respiratory programs and portfolio, including new and lifecycle management programs.
9. Build and maintain collaboration with internal stakeholders across various departments.
10. Participate in ad boards, respiratory forums, and meetings, and engage with regulators on clinical development pathways.
11. Develop projects and evaluate new business opportunities or internal Target Drug Candidates for pipeline expansion.
12. Drive the overall strategy and delivery of respiratory programs from candidate evaluation through registration.

Knowledge and Education :

Educational Qualifications : MD / MS in Internal and Pulmonary / Critical Care Medicine.

Experience : Minimum 18 years of experience as a practicing pulmonary clinical professional, with over 5 years in the pharmaceutical industry or clinical projects in clinical development, including regulatory interactions.

Knowledge and Skills : Expertise in drug development, scientific advocacy with policymakers/regulators.

Behavioral Attributes : Good decision-making and influencing skills, strong interpersonal skills.